To Evaluate the Technique and Effects of Separating the Prostate and Rectum With Hyaluronic Acid During Radiotherapy

Phase 2

• Conditions: Prostatic Cancer
• Interventions: Device: Hyaluronic acid

• Registration Number: NCT01787630
• Lead Sponsor: Anders Widmark

Brief Summary

The dominating problem after local radiotherapy of prostate cancer is rectal toxicity. If the rectum could be completely moved out of the treated volume, a substantial decrease of rectal toxicity seems reasonable. In this study we will develop and evaluate a new transrectal injection technique where hyaluronic acid (HA) is injected in the space between the prostate and the rectum prior to external beam radiotherapy to increase the physical distance between prostate and rectum.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2013-02-06
• Study First Submitted QC: 2013-02-06
• Study First Posted: 2013-02-08
• Primary Completion: 2016-03
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-03
• Last Update Posted: 2016-11-04
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 81

Inclusion Criteria

• Histologically verified prostatic cancer
• Low or intermediate risk prostatic cancer
• Lymph node negative
• Suitable for radiotherapy

Exclusion Criteria

• Earlier treatment for prostatic cancer
• Unable to co-operate or suffering from any other form of disease that would interfere with the planned treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hyaluronic acid	Hyaluronic acid	Hyaluronic acid will be injected in the space between the prostate and rectum prior to radiotherapy to perform a dorsal movement of rectum.

Primary Outcome Measures

Name	Time	Method
Remaining volume of HA	24 month after end of radiotherapy	Measurement on the remaining volume of HA by MRI

Secondary Outcome Measures

Name	Time	Method
Quality of life	24 month after end of radiotherapy	Patient evaluation with questionnaires regarding Quality of Life and side effects after radiotherapy

Trial Locations

Locations (3)

Department of oncology, Kalmar Hospital; 🇸🇪 Kalmar, Sweden

Department of oncilogy, Sundsvall Hospital; 🇸🇪 Sundsvall, Sweden

Department of oncology, University Hospital; 🇸🇪 Umeå, Sweden